Practical Advice for Successful Partnering between Innovator Drug Delivery Companies and Big Pharma

Deborah Bitterfield has over 10 years of experience in the biopharmaceutical industry and currently serves as the President and CEO of Lindy Biosciences, Inc., which she founded in 2017. Dr Bitterfield’s experience reflects positions across a broad range of strategic and operational disciplines including biotherapeutics and medical devices. Prior to launching Lindy Biosciences, Dr Bitterfield joined Southeast TechInventures, an innovation lab that partners with university inventors to further develop promising university technologies, where she led their scientific operations and project management. She holds a PhD in Materials Science from Duke University with a focus in biomaterials.

Michael Cucolo is an experienced Business Development Executive Director at Bristol-Myers Squibb Company (BMS) with a passion for partnering. With over 25 years in the pharmaceutical industry, Michael has held positions of increasing responsibility at American Cyanamid’s Lederle Pharmaceuticals, Cytogen, Ohmeda, and BMS. In his current role, he identifies and transacts opportunities to support, grow, and advance BMS's pipeline. Previously, he led a Research Enabling Technologies Team, seeking opportunities, establishing collaborations, and licensing novel platforms for BMS. Michael has structured deals, partnerships, and negotiated over 150 diverse transactions, including material transfers, evaluations, technology platform/asset in-licensing/out-licensing, and collaborations with industry, pharma/biotech, venture capital, and academic partners. His broad experience spans the searching, evaluation, and licensing of assets and technologies in support of pharmaceutical discovery, drug delivery, development, and manufacturing for both small and large molecules. He enjoys learning about the ever-evolving drug delivery approaches being developed to better administer medicines to patients. Michael began his career in formulation development and delivery of novel drug products, transitioning them to manufacturing for early clinical trials. As a scientific investigator, he worked extensively on the development of both small molecules and biologics, contributing to several marketed pharmaceuticals and holding two drug formulation patents.Michael Cucolo is an experienced Business Development Executive Director at Bristol-Myers Squibb Company (BMS) with a passion for partnering. With over 25 years in the pharmaceutical industry, Michael has held positions of increasing responsibility at American Cyanamid’s Lederle Pharmaceuticals, Cytogen, Ohmeda, and BMS. In his current role, he identifies and transacts opportunities to support, grow, and advance BMS's pipeline. Previously, he led a Research Enabling Technologies Team, seeking opportunities, establishing collaborations, and licensing novel platforms for BMS. Michael has structured deals, partnerships, and negotiated over 150 diverse transactions, including material transfers, evaluations, technology platform/asset in-licensing/out-licensing, and collaborations with industry, pharma/biotech, venture capital, and academic partners. His broad experience spans the searching, evaluation, and licensing of assets and technologies in support of pharmaceutical discovery, drug delivery, development, and manufacturing for both small and large molecules. He enjoys learning about the ever-evolving drug delivery approaches being developed to better administer medicines to patients. Michael began his career in formulation development and delivery of novel drug products, transitioning them to manufacturing for early clinical trials. As a scientific investigator, he worked extensively on the development of both small molecules and biologics, contributing to several marketed pharmaceuticals and holding two drug formulation patents.

For the past 30 years, Vincent Ling, PhD, led successful groups in diverse biotechnology fields including cell devices, protein engineering, biosimilars, stem cell differentiation, checkpoint inhibitors and molecular evolution of antibody scaffolds. He has held leadership positions in large, mid-sized and start-up environments, creating practical biotherapeutics. His current interests lie in novel drug delivery technologies, which includes drug particles, energy guidance and biomaterial scaffolds. At Takeda, Dr Ling currently serves as Senior Director within Search and Evaluation, Business Development, after directorship roles in external innovation and pharmaceutical sciences. Prior to Takeda, Dr Ling was Head of Biological Sciences developing cell therapies for wet AMD at Neurotech. He has held positions including Vice President at Dragonfly Sciences, managing all scientific operations and marketing functions, Director of Molecular Genetics at Adnexus (Compound Therapeutics), and other scientific roles in Discovery Research at Genetics Institute and Wyeth Pharmaceuticals.

John A. Merhige is Chief Commercial Officer at Credence MedSystems. Previously, Mr Merhige was Vice President, Market Development at Sanofi BioSurgery. He joined Sanofi upon its acquisition of Pluromed, Inc, where Mr Merhige was the third employee and member of the executive management team. Pluromed developed and commercialized rapid transition polymers for use in cardiovascular and other surgical procedures. Previously, Mr Merhige founded Prelude Devices to identify early stage medical device ventures and gained general management and commercial leadership experience at Ford and Avery Dennison. Mr Merhige graduated from Dartmouth College with a mechanical engineering degree and returned to Dartmouth for a Masters in Engineering Management from the Thayer School of Engineering and the Tuck School of Business. Mr Merhige is a member of MassMEDIC, MassBio and has served on the board of directors of the MedDev Group (MDG).

Sarah Tao, PhD, is the Head of Search & Evaluation, Technology Platforms within Global Business Development & Licensing at Sanofi. In this role, she is responsible for identifying and evaluating external technologies that align with Sanofi’s strategies for its therapeutic modalities. Dr. Tao joined Sanofi in 2017 as Technology Lead for Biologics Research with successive roles in Research before shifting to Business Development in 2021. Prior to Sanofi, Dr. Tao was a Senior Manager of New Technologies at CooperVision leading external research programs, and was also a Senior Member of the Technical Staff in the MEMS Design Group at Draper Laboratory. She received her Ph.D. in Biomedical Engineering from Boston University with a research focus on MEMS-based devices for oral drug delivery, and has received numerous accolades for her contributions to the field of drug delivery, including the Controlled Release Society Grand Prize.